Methods and devices for treating obesity and GERD by intussuscepting a portion of stomach tissue

ABSTRACT

Described here are devices and methods for intussuscepting a portion of stomach tissue. Typically the intussusception is created at a position near, but distal to the gastroesophageal junction, and a pouch capable of storing a volume (from about 0 cc up to about 100 cc) is created proximal the intussuscepted tissue. In this way, the amount of food that may be ingested is reduced, helping to ameliorate GERD symptoms, and aiding in weight loss efforts. Some of the devices described here include an expandable member and at least one suction inlet. In these devices, the expandable member is expanded to create a proximal cavity into which the stomach tissue is pulled (e.g., using suction), thereby creating the intussusception.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/870,096, filed on Oct. 10, 2007, which claims priority to U.S.Provisional Patent Application Ser. No. 60/854,167, filed on Oct. 26,2006, each of which are hereby incorporated by reference in theirentirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

REFERENCE TO A COMPACT DISK APPENDIX

Not applicable.

BACKGROUND OF THE INVENTION

Obesity and gastroesophageal reflux disease (GERD) both impact asubstantial number of people in society. Therapies exist to treat thesediseases; however, many of the current therapies have limitations thatresult in only a sub segment of the market receiving treatment. Spurredby the continuing growth of these diseases, new therapies are beingdeveloped to address these limitations.

Current therapies for obesity range in invasiveness and efficacy. Theleast invasive therapies include diet, exercise, and pharmaceuticals.These therapies have not yet shown significant weight loss over thelong-term. More invasive treatment options include weight losssurgeries, such as gastric bypass, vertical banded gastroplasty, andadjustable gastric banding. These procedures share at least one commonelement, namely, restricting stomach size. These procedures have shownlong-term weight loss, but carry significant surgery-associated risks.

New devices are being developed to achieve the efficacy of weight losssurgery, while employing less invasive procedures. These devices utilizemechanisms of action that include restricting stomach size, stimulatingthe stomach (e.g., using electrical stimulation), filling a portion ofthe stomach with a space-occupying member, and introducing one or moremalabsorptive elements into the stomach. While the invasiveness of theweight loss procedures has been reduced, the new mechanisms of actionremain to be clinically proven. Additionally, many of the new weightloss devices are large and bulky, which reduces ease of use and may leadto long procedure times.

In addition, treatment of GERD follows a progression of therapies.Initially, lifestyle modifications, which include changes to diet, areutilized. If symptoms persist, the next level of treatment is typicallypharmacologic therapies, which range from antacids to proton pumpinhibitors. These therapies tend to be tolerated over the long-term. Formore severe cases of GERD, or for cases where patients seek a one-timetreatment, surgery may be required. The most common surgical procedureis fundoplication, which has good efficacy but carries the inherentrisks of surgery.

Similar to new obesity treatments, new GERD treatments seek to obtainthe efficacy of surgery but in a less invasive manner. These therapiesseek to reduce the esophageal aperture via mechanisms of actionincluding radio frequency ablation, esophageal cinching, and tissueplication.

Due to the great need in the areas of obesity and GERD, the developmentof additional less invasive device solutions is desirable.

BRIEF SUMMARY OF THE INVENTION

Described here are devices and methods for intussuscepting a portion ofstomach tissue. Typically the intussusception is created at a positionnear, but distal to the gastroesophageal junction, and a pouch capableof storing a volume anywhere from 0 cc up to about 100 cc is createdproximal to the intussuscepted tissue. In this way, the amount of foodthat may be ingested is reduced, helping to ameliorate GERD symptoms,and aiding in weight loss efforts. In addition, the gastric reductionvolume can provide negative feedback to reduce the desire to eat.

In some variations, the devices comprise an expandable member and atleast one suction inlet. In these variations, the expandable member isexpanded to create a proximal cavity into which the stomach tissue ispulled (e.g., using suction), thereby creating the intussusception. Thedevices typically comprise a main shaft, having a lumen therethrough,through which an endoscope or other suitable device may be advanced. Theexpandable member may or may not be releasably attached to the mainshaft of the device. It should be understood that some variations of thedevices described here do not employ an expandable member or suction.

The devices may further comprise one or more anchor introducers forhousing one or more anchors therein, which can be deployed through theanchor introducers, and thereby secure the intussuscepted tissue. Theone or more anchor introducers are typically radially expandable (e.g.,by an expandable balloon, expandable cage, one or more radiallyexpanding prongs, or the like) to position the anchor introducersadjacent to the intussuscepted tissue. Any number of anchor introducersmay be used for housing any suitable number and type of anchors (e.g.,T-tags, V-tags, H-tags, etc.). The devices may further comprise aprotecting portion to limit movement of the anchor introducers.

The devices may also comprise a retaining material, e.g., to help securethe intussuscepted tissue. In some variations, one or more anchors areconfigured to pierce through the retaining material, helping to securethe intussusception. The retaining material may or may not be positionedabout at least an inner portion of the expandable member, may or may notbe continuous, may or may not have a uniform thickness, and may or maynot be adjustable.

The devices may also comprise a sizing component for sizing a pouch tobe created proximal to the intussuscepted tissue, in order to limit theamount of food that may be consumed. In some variations the devicesdescribed here further comprise a retractable sheath that covers atleast a distal portion of the device.

Methods for intussuscepting a portion of stomach tissue are alsoprovided. In some variations, the methods comprise creating anintussusception with stomach tissue distal to a gastroesophagealjunction and deploying one or more anchors through the intussusceptedtissue to secure the intussusception. In some variations, theintussusception is created in a single step. The anchors may or may notbe deployed through the intussuscepted tissue simultaneously, and may ormay not be positioned adjacent to the intussuscepted tissuesimultaneously. The methods may further comprise positioning at leastone retaining material adjacent to the intussusception prior todeploying one or more anchors through the intussuscepted tissue. Inthese variations, the one or more anchors are most typically deployedthrough at least a portion of the retaining material.

A pouch is created proximal to the intussuscepted tissue, which servesto reduce the amount of food capable of being consumed. The pouch may beof any suitable size and is typically capable of retaining any volume,from 0 cc up to about 100 cc of volume. The volume of the pouch may becontrolled or otherwise determined using a sizing component, such as anexpandable balloon.

The intussusception may be created in any suitable manner, and in somevariations, it is created by suction. For example, in some variations,it is created by transorally advancing a device to a position distal toa gastroesophageal junction, where the device comprises an expandablemember and a suction inlet. The intussusception may then be created withthe expandable member and suction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a simplified depiction of the human stomach.

FIG. 1B provides a cross sectional view of the various stomach layers.

FIG. 2 shows an overview of an illustrative device described here.

FIGS. 3A and 3B provide detailed depictions of a distal portion of adevice described here, having a collapsed and an expanded configurationrespectively.

FIG. 3C provides an illustration of one variation of an expandablemember.

FIGS. 4A-4F provide illustrative variations of suitable retainingmaterials for use with the devices and methods described here.

FIG. 5 provides a close-up illustration of an expandable member that maybe used with the devices and methods described here.

FIGS. 6A and 6B provide detailed views of a suction line and suctioninlets that may be used with the devices and methods described here.

FIG. 7A shows a detailed view of a subassembly of an illustrative deviceshowing anchor introducer grooves, and FIG. 7B provides across-sectional view of the device of FIG. 7A, taken along plane B.

FIG. 8 provides an illustration of how an anchor may be housed within ananchor introducer.

FIGS. 9A-9C depict variations of proximal controls.

FIG. 10 shows how a pouch is created proximal to intussuscepted tissue,which may be created using the devices and methods described here.

FIGS. 11A-11J depict an illustrative method of creating anintussusception in a portion of stomach tissue.

FIGS. 12A-12D depict anchor deployment in accordance with one variationof the methods described here, in more detail.

DETAILED DESCRIPTION OF THE INVENTION I. Overview and Anatomy

Described here are devices and methods for treating obesity and GERD byintussuscepting a portion of the stomach. The intussusception is createdat a target location distal of the gastroesphageal junction, such that asmall pouch, able to contain a volume from 0 cc up to about 100 cc ofvolume, is left proximal the intussuscepted tissue. As used herein, theterms “intussuscept,” “intussusception,” “intussuscepting,” and the likerefer to the creation of a continuous tissue fold created by telescopingone part of the stomach onto or into another part of the stomach. Thedevices enable (though need not be used in such a fashion) tissueintussusception in a single step, which could greatly reduce proceduretime.

FIG. 1A shows a simplified depiction of stomach (100) and itssurrounding anatomy. Shown there is esophagus (102) and duodenum (104)in fluid communication with stomach body at its proximal and distal endsrespectively. Also shown is fundus (106), gastroesophageal junction(108), and lesser and greater curvatures (110) and (112) respectively.FIG. 1B provides a simplified cross sectional view of the variousstomach layers. Shown there is serosa layer (114), muscle layer (116),and mucosa layer (118).

II. Devices

The devices for treating obesity and GERD described here serve tointussuscept a portion of the stomach and to secure the stomach in itsintussuscepted configuration. Some of the devices described herecomprise an expandable member and at least one suction inlet, where theexpandable member is expanded to create a proximal cavity into which thestomach tissue is pulled using suction, thereby creating theintussusception. In other of the devices described here, expandablemembers and suction are not used to create the intussuscpetion. One ormore anchors may be deployed to secure the intussusception, with orwithout a retaining band or other material, as will be described indetail below.

FIG. 2 shows an overview of device (200) having proximal portion (202)and distal portion (204). Distal portion (204) is shown in greaterdetail in FIGS. 3A and B and various proximal portions are described ingreater detail with reference to FIGS. 9A, 9B, and 9C.

Shown in FIG. 3A is one variation of distal portion (204), includingsheath (302), holder (304), anchor introducers (305), anchor introducerexpander (306), main shaft (307), retaining material (308), expandablemember (309), and sizing component (312). In this variation, sheath(302) covers most of distal portion (204), and is slidable with respectto distal portion (204). In this way, the device (200) may be advancedin a low profile manner to a target site of interest. The sheath mayalso serve to protect the individual components of the device (200) fromdisrupting esophageal tissue while the device (200) is advanced to atarget location transorally. While shown in FIG. 3A as having a lengththat covers most of distal portion (204), the sheath (302) need not havesuch a length. Indeed, the sheath (302) may only cover a portion ofdistal portion (204), and in some variations, the sheath (302) onlycovers or partially covers expandable member (309). In other variations,the device simply does not comprise a sheath. When a sheath is used, itmay be made of any suitable biocompatible material, and is mosttypically in the form of a flexible tube (e.g., a polymeric tube, suchas one made of polyesters, polyimides, polyurethanes, combinationsthereof, and the like). The sheath may also comprise one or more metals,which may be formed in any suitable fashion (e.g., braided metallicribbons, coils, and the like). Suitable metals include, but are notlimited to, stainless steel, aluminum, nickel-titanium alloys, andcombinations thereof. In some variations, when the sheath (302) iswithdrawn proximally, sizing component (312) and/or the expandablemember (309) automatically expands. In these variations, the sizingcomponent and/or the expandable member is made of a self-expandablematerial, as will be described in more detail below. The sheath (302) isshown partially withdrawn or proximally retracted in FIG. 3B.

Holder (304) is configured to hold, house, couple to or with, orotherwise engage anchor introducers (305) at their proximal ends (or attheir proximal portions). Holder (304) should be made of a biocompatiblematerial, and is typically in the form of a flexible tube. The holdermay be made of the same or different materials, than those of thesheath. Anchor introducers (305) may be held or otherwise attached toholder (304) in any suitable manner. For example, the anchor introducers(305) may be held in grooves formed in holder (304), the grooves havingshapes corresponding to the shapes of the outer surfaces of the anchorintroducers (305). The anchor introducers (305) may be snap-fit into orwith the holder (304), but need not be. Indeed, the anchor introducersmay simply be held in a friction-fit fashion between the grooves in theholder (304) and the main shaft (307) of the device. The anchorintroducers (305) may also be attached to the holder (304) mechanically(e.g., using pins, screws, etc.), by using glue or other adhesives, orthe like. The anchor introducers may also be housed within a portion ofthe expandable member, or a housing off the expandable member (309).

The anchor introducers (305) shown in FIG. 3A have tissue-piercing tips,but the tips need not be tissue-piercing and the tips need not bepointed. They may be blunt, or may have points with one or more beveledsurfaces thereon. The anchor introducers (305) are typically made of aflexible material having a lumen capable of housing one or more anchorstherein, although it should be understood that the anchor introducersneed not be made of a flexible material. The anchor introducers may bemade of the same or different materials, than those of the sheath. Insome variations, the anchor introducers (305) are made of stainlesssteel hypotubes. While two anchor introducers (305) are shown in FIG. 3Aand five are shown in FIG. 3B, any number of anchor introducers (305)may be used (e.g., 1, 2, 3, 4, 5, 6, or more). In some variations thedevice comprises one anchor introducer (305). In other variations, thedevice comprises six or more anchor introducers (305). Also, while theanchor introducers (305) are shown in FIGS. 3A and 3B as having the samelength, the anchor introducers (305) may have different lengths, and maybe arranged in any suitable configuration. For example, the anchorintroducers (305) may be uniformly spaced or non-uniformly spaced, andmay or may not be spatially layered (i.e., the tips or ends of theanchor introducers may be closer or further from the main shaft (307)).

The anchor introducers (305) are typically configured to radially expandand pierce through an intussusception, although as noted above, theanchor introducers need not be configured to pierce through tissue(e.g., may instead be used to position the anchors prior to deployment).In the variation shown in FIGS. 3A and 3B, the anchor introducers (305)are also configured to pierce through at least a portion of retainingmaterial (308), and are expanded by anchor introducer expander (306).After at least a portion of the retaining material (308) has beenpierced by the anchor introducers (305), one or more anchors aredeployed therethrough, as will be described in more detail below withreference to the methods. FIG. 3C depicts an alternate placement for theanchor introducers (305) where they are positioned at the ends of anexpandable member (309). The anchor introducer expander (306) may be anysuitable component capable of aiding the radial expansion of the one ormore anchor introducers (305). For example, the anchor introducerexpander (306) may be a balloon (as shown in the variation of FIGS. 3Aand 3B), an expandable cage, one or more radially expanding prongs, orthe like. The anchor introducer expander (306) may also be a pulleysystem, a pulling mechanism, or the like. It need not be a singlecomponent as depicted in FIGS. 3A and 3B.

The retaining material (308) should be made of a material capable ofretaining the stomach tissue in its intussuscepted configuration. Forexample, the retaining material may be made of an elastomeric material,such as biocompatible rubbers, polyurethanes, polyesters, nylons, etc.),may be made of a super-elastic or shape memory material (e.g.,nickel-titanium alloys and the like), or may be made of other suitablematerials. The material may be porous (e.g., mesh like, or woven innature), or may not be. The retaining material may be continuous, or maybe non-continuous in nature (e.g., made from more than oneinterconnected or interlocked pieces). All, or any portion of theretaining material may be coated, impregnated, or otherwise include aradiopaque or echogenic tag or marker to aid in visualization. Thematerial may be configured for permanent placement in a stomach (i.e.,be biocompatible and able to withstand stomach acids and the stomachenvironment generally) or be configured for temporary placement (i.e.,be made of a biodegradable material). In instances where sufficientfibrosis is expected to occur, the retaining material may be configuredto degrade over time, leaving a permanent fibrosed intussusceptedconfiguration. In some variations, the retaining material (308) isconfigured for permanent placement and is made of a continuous band ofmaterial as shown in FIGS. 3A and 3B. As will be described in moredetail with reference to FIGS. 4A-4F, the retaining material (308) maybe of any suitable shape, be continuous or non-continuous, and have auniform or non-uniform thickness. In the variation shown in FIGS. 3A and3B, retaining material (308) is positioned along at least an innerportion of expandable member (309), such that when expandable member(309) is expanded, and at a least a portion of the stomach isintussuscepted into a proximal cavity of the expandable member (309),the retaining material (308) abuts the intussuscepted tissue and retainsthe intussuscepted configuration when one or more anchors are placedtherethrough.

The devices described here may further comprise a sizing component(312), shown in its delivery configuration in FIG. 3A and its deployedconfiguration in FIG. 3B. The sizing component (312) helps to positionthe distal portion (204) of the device past the gastroesophagealjunction, and also serves to ensure that there is enough stomach volumeabove the intussuscepted tissue. The sizing component (312) may alsohelp facilitate the placement of the distal portion of the devicerelative to the stomach wall (e.g., by helping with angle positioning,etc.). In some variations, such as the variation shown in FIGS. 3A and3B, the sizing component (312) is a balloon. The sizing component (312)may also be an expandable cage, one or more radially expandable prongs,or the like, and may be manually expanded or self-expanding with theremoval of the sheath (302).

Also shown in FIG. 3A is suction line (310) with suction inlet (316),and endoscope (314). The suction line (310) is configured to providesuction to stomach tissue to create the intussusception. While shown inFIG. 3A as located adjacent to main shaft (307), the suction line (310)and suction inlet (316) may be placed at any convenient location capableof making the intussusception. As shown in FIG. 3B, the suction inlet(316) is positioned centrally with respect to the expandable member(308). This variation may be desirable to help ensure proper suction ofthe stomach tissue to create an intussusception of suitable depth whileminimizing risk of obstruction. Any number of suction lines (310) andsuction inlets (316) may be used. Alternatively, in variations where theendoscope (314) already has a port that enables suction, the endoscopemay be positioned adjacent to the suction inlet (316) to provide asuction channel for helping to create an intussusception.

Endoscope (314) may be any suitable endoscopic device to provide forvisualization during the creation and securing of the intussusception.For example, the endoscope may be a pediatric endoscope, or similarendoscope having a low profile. Other scopes or devices may also beinserted through, or alongside of, the lumen of main shaft (307), ifdesirable or useful.

FIG. 3B shows distal portion (204), where sheath (302) has beenpartially retracted, and sizing component (312), expandable member(309), and anchor introducer expander (306) are all shown in expanded orpartially expanded configurations. The devices described here may alsocomprise a protective portion (318), which is also shown in FIG. 3B.Protective portion (318) may be useful to prevent anchor introducers(305), or anchors, from penetrating too deeply into or through thestomach tissue. For example, the protective portion (318) serves toprevent the anchor introducers (305) from puncturing through to theoutside of the stomach wall, where the puncturing is not associated withthe securing of the intussusception (it should be understood that theanchor introducer pierces through to the outside of the stomach wallduring the securing of the intussusecption, as will be discussed in moredetail with reference to the methods). Protective portion (318) alsoprevents anchors from being deployed adjacent to a serosal layer.Protective portion (318) is shown in FIG. 3B as a continuous band ofmaterial, though it need not be. For example, the protective portion maybe folded in a fan-shape so that, e.g., it may be expanded when theexpandable member is fully expanded, or may be a thin flab of a metallicmaterial, that is attached to the expandable member, or componentsthereof. Alternatively, the protective portion may comprise a safetymechanism in the anchor introducers or expandable member that limitsdeployment of anchor introducers or anchors, to a safe range. Theprotective portion may be made of any suitable material. For example,the protective portion may be made of one or more polymers, e.g.,polystyrene, polypropylene, polyethylene (such as high-densitypolyethylene, ultrahigh molecular weight polyethylene, and the like),KEVLAR®, etc. Similarly, the protective portion may be made of one ormore metals (e.g., stainless steel, aluminum, or the like). Theprotective portion may also be made of a combination of materials (e.g.,a combination of one or more polymers and metals, etc.). In somevariations, e.g., where a portion of the expandable member (309) servesthe above functions, the protective portion (318) may not be necessary.

As mentioned briefly above, the retaining material may have any suitablegeometry or configuration, and may be continuous or discontinuous. FIGS.4A-4F provide various depictions of suitable retaining materials. Shownin FIG. 4A is a variation of retaining material (400) in the form of acontinuous band of material having a uniform diameter. FIG. 4B is anillustration of retaining material (402) having an inflatable portion(403). FIGS. 4C and 4D provide side views of variations of retainingmaterials having a non-uniform thickness, and FIG. 4E provides a topview of a variation having a non-uniform thickness. FIG. 4F depicts aretaining material (410) having a generally conical configuration (andthe conical configuration can be applied to any suitable shape). Theretaining material may or may not be adjustable (either in length,height, or thickness) in situ. In variations where the retainingmaterial is adjustable, the retaining material may comprise one or moreinflation cavities or lumens, and adjustability may be achieved byfilling (and thus inflating) the one or more cavities or lumens with aspace filling substance or member (e.g., water, saline, air, carbondioxide, etc.). The retaining material may also be made adjustable byuse of a ratcheting mechanism, on or in combination with, the retainingmaterial. In addition, the retaining material may or may not have one ormore portions resistant to puncture or piercing by the anchorintroducers or by the anchors themselves. For example, one surface(e.g., outer surface) of the retaining material may be made of anon-puncturable material (e.g., a relatively rigid material). One ormore surfaces of the retaining material (308), or a part thereof, may betransparent, translucent, radiolucent, echolucent, or the like to aid invisualization (either endoscopically, or with an alternative device,such as with ultrasound).

FIG. 5 provides a close-up illustration of an expandable member (309),suitable for use with the devices and methods described herein. In thisvariation, the expandable member (309) comprises a series of radiallyexpanding prongs. Any number of prongs may be used. While the prongsshown here are equally spaced apart, they need not be. Indeed, thespacing between the prongs may or may not be uniform. In addition, theprongs may be asymmetrically be deployed, be of different lengths, andmay expand radially at individually differing angles (e.g., to aid inthe creation of an intussusception of suitable depth and geometry). Theprongs may thus be positioned to form any suitable geometry, e.g., anoval, a circle, etc. It should also be understood, that when the prongsof FIG. 5 are fully expanded, portions (502) and (504) are angled awayfrom the main shaft (307), this need not be so. Indeed, in othervariations, one or more of portions (502) and (504) are parallel with orangled towards the main shaft (307) when fully expanded. In thevariations shown here, the expandable member may be hyper expanded, suchthat the prongs flip over and collapse, leading to a collapsibleconfiguration for easy release of a retaining material, should it beused, and withdrawal of the device. In addition, while the expandablemember (309) is shown having two portions (502) and (504), theexpandable member may be monolithic in nature, comprising a singleunitary body. A transparent, translucent, or opaque material may coverat least a portion of the expandable member (309), if desirable.

The device may further comprise one or more locking mechanisms to lockthe expandable member in an expandable configuration. The expandablemember may also be re-usable. In these variations, the expandable memberis configured for releasable attachment or coupling to the main shaft(307), and is made of a sterilizable material. In these variations, theremainder of the device may or may not be disposable. As mentionedbriefly above, the expandable member may also be configured forself-expansion upon proximal withdrawal of the sheath. In thesevariations, the expandable member is made of a shape memory material,such as shape memory alloys (e.g., a nickel titanium alloy or the like)or shape memory polymers, or is made of a material having sufficientelasticity, such that it will spring to its expanded configuration whenthe sheath is withdrawn.

FIGS. 6A and 6B provide more detailed views of the suction line and thesuction inlets that may be used with the devices and methods describedherein. Specifically, FIG. 6A shows a subassembly (600) of the devicecomprising an expandable member (602) coupled or attached to a mainshaft (604), having one or more suction inlets (606). FIG. 6B providesan exploded cross-sectional view of FIG. 6A, showing suction line (608)and suction inlets (606). As mentioned briefly above, any number ofsuction lines (608) and suction inlets (606) may be used as desirable,and in variations where the inlets are located about the main shaft(604), the inlets may or may not be uniformly spaced apart. The inletsmay have any suitable geometry or pattern along the length. They neednot be circular as depicted in FIGS. 6A and 6B. Similar to the anchorintroducers, the suction lines may be on the expandable member itself.

FIG. 7A shows device subassembly (700) comprising shaft (702), holder(704), anchor introducers (706), and anchor introducer expander (708).Also shown in FIG. 7A are grooves (710) in holder (704) for retaininganchor introducers (706). In FIG. 7A, anchor introducer expander (708)is shown as a balloon in its expanding configuration, urging anchorintroducers (706) radially outward. FIG. 7B shows a cross-sectional viewof FIG. 7A taken along plane B.

FIG. 8 provides an illustration of how an anchor (in this variation aT-tag, 802) may be housed within anchor introducer (800). In thisvariation, T-tag (802) is friction fit within the lumen of anchorintroducer (800), but other variations are possible. For example, asuture material or the like may be coupled to the anchor. Alternatively,part of the anchor may reside outside a delivery shaft, as common intagging guns. The anchor may also reside in between a push-rod (804) onthe proximal side, and a stopper (not shown) on the distal side. Alsoshown in FIG. 8 is push-rod (804) for deploying T-tag (802) from distalend (806) of anchor introducer (800), but other anchor deploymentmechanisms are possible (e.g., pneumatic, hydraulic, magnetic, or thelike). Any suitable number of anchors may be used, and the anchors maybe preloaded in the anchor introducer (800), or may be loaded intoanchor introducer (800) immediately prior to use. The anchors may alsobe housed within a replaceable cartridge, and the cartridge preloadedprior to use.

Any suitable anchor geometry may be used. For example, the anchor may bea T-tag, H-tag, V-tag, coil, clip, staple-like anchor, hoop, hook, barb,or the like. In variations where the anchor has one or more anchor ends,the anchor ends may have any suitable shape, e.g., disc, “X-shape,”rectangle, etc., and the shapes need not match on all or any ends. Insome variations, it may be desirable to increase the surface area of theanchor ends. The anchor may be a single injection-molded piece, or maybe comprised of one or more pieces held together by a filament or thelike. In these variations, the pieces may be made of the same ordifferent material, and in some variations, the filament is made of amaterial having a greater elasticity than the anchor ends. The materialmay be permanent or degradable. In addition, the anchor may also beconfigured for easy retraction in the event that it is misfired orpositioned in a fashion that is otherwise unsatisfactory to the user. Inthese variations, the anchor may be withdrawn back into the anchorintroducer (800), repositioned, and redeployed. Additional anchors maybe loaded into the anchor introducer (800) without removing the devicefrom the patient.

FIGS. 9A-9C show variations of proximal control. Shown in FIG. 9A isproximal portion (900) comprising handle (901) having knobs (902) and(904) thereon. Knob (902) may for example, be used to control theexpansion of the expandable member. The knob (902) may be configured forcontinuous turning, or may be configured to lock periodically as theexpandable member reaches various points of expansion. Knob (904) may beused, for example, to actuate or control the push-rod or other actuationmechanism for anchor deployment. Also shown connected to handle (901) isworking channel (905) having one or more ports (906) thereon. Theadditional ports (906) may be used for suction, inflation, or the like.The handle may provide feedback for each step of the procedure via afeedback mechanism (907). The feedback mechanism (907) may provideresistance, pressure force feedback, visualization, auditory, tactile,or any other type of feedback to guide the procedure. FIG. 9B provides avariation (908) similar to the variation provided in FIG. 9A except thatknob (904) has been replaced with finger actuated trigger switch (912).Of course, any combination of knobs and triggers, or the like, may beused to actuate or expand the various device components described justabove. FIG. 9C shows a variation of proximal control having arms (916and 918) that may be brought together (e.g., by squeezing action) inorder to actuate one or more components of the devices described justabove.

III. Methods

Also described here are methods for treating obesity and GERD byintussuscepting a portion of the stomach and securing theintussusception. In some variations the methods comprise creating anintussusception with stomach tissue at a position distal to agastroesophageal junction using suction, and then deploying one or moreanchors through the intussuscepted tissue to secure the intussusception.

In general, the methods described here are used to create a pouch (1000)proximal to the intussuscepted tissue (1002), as shown in FIG. 10. Inthis way, a small or reduced stomach space is created (e.g., capable ofholding anywhere from 0 cc up to about 100 cc of volume) and food intakewill be limited. In addition, creation of a small proximal pouch (1000)may help provide negative reinforcement to over eating, because if toomuch food is consumed, it will back up into the esophagus, discouragingadditional eating. The intussusception may also act as a valve to reduceacid reflux associated with GERD.

FIGS. 11A-11J depict the creation of an intussusception and a proximalpouch in accordance with the methods described herein. As shown in FIG.11A, an intussusception device (1100) (such as any of the devicesdescribed just above) is advanced transorally through the esophagus(1102) and into the stomach (1104). In some variations, theintussusception device (1100) defines a lumen therethrough, and thedevice (1100) is advanced over an endoscope (1106). The device (1100)may or may not be advanced simultaneously with the endoscope (1106). Forexample, in some variations, the device (1100) and endoscope (1106) areadvanced in a side-by-side fashion, or are advanced serially, in anon-coupled fashion. The device (1100) may or may not be advanced with asheath covering a length of the device, as described above.

After the intussusception device (1100) has been advanced to a positionadjacent target tissue, the endoscope (1106) is retroflexed to providevisualization of the target tissue (and in some instances theintussusception device itself), as shown in FIG. 11A. Once theintussusception device (1100) has been advanced such that the sizingcomponent (1108) is positioned distal of the gastroesophageal junction(1103), the sizing component (1108) is expanded or otherwise actuated toprovide an expanded or second configuration. The sizing component (1108)shown throughout FIG. 11 is an expandable balloon, but as mentionedabove with reference to the devices, the sizing component (1108) may beany suitable component capable of preventing the sizing component (1108)from being proximally withdrawn past the gastroesophageal junction(1103). In this way, the sizing component (1108) may be pulledproximally once expanded (e.g., by pulling proximally on intussusceptiondevice 1100)), to abut the gastroesophageal junction (1103), in order tofacilitate the sizing of a proximal pouch (1000) with sufficient volumecapacity. The sizing component (1108) may have any suitable size and beof any suitable shape, as described above. In some variations, thesizing component (1108) is configured to facilitate the sizing of aproximal pouch (1000) capable of retaining a volume anywhere from 0 ccup to about 100 cc of volume. In some variations, the proximal pouch(1000) is sized without the use of a sizing component (1108), forexample, by direct visualization of the gastroesophageal junctionanatomy, or with the use of a positioner to help ensure proper spacingfrom the gastroesophageal junction. In some variations, the sizingcomponent (1108) also facilitates placement of the intussusceptiondevice (1100) at an advantageous angle within the stomach.

Once the proximal pouch (1000) has been spatially defined (e.g., using asizing component, positioner, or by direct visualization), an expandablemember (1110), such as those described above, is expanded into anexpanded configuration as shown in FIG. 11B. In this way, the expandablemember defines a proximal cavity (1114) into which the stomach tissuemay be pulled, in order to create the intussusception (e.g., usingsuction). After the expandable member (1110) is expanded, it may belocked in the expanded configuration, but need not be. Suction may thenbe applied (e.g., via one or more suction inlets) to begin to pullstomach tissue into the proximal cavity (1114) as shown in FIGS. 11C and11D to create the intussusception. The expandable member (1100) may ormay not be adjusted to vary the amount of expansion after suction hasbegun. The stomach tissue may also be pulled into proximal cavity (1114)by other mechanisms other than suction (e.g., using graspers, hooks,adhesives, etc.). The creation of the intussusception (1002) may or maynot be performed in a single step.

After the intussusception (1002) is created, it may be secured(permanently or temporarily), for example, by deploying one or moreanchors through the intussuscepted tissue. In some variations, theanchors are deployed through at least a portion of retaining material(1112), in other variations the anchors are deployed directly throughthe intussuscepted tissue. As described above, when a retaining material(1112) is used, it may or may not be coupled to the expandable member(1110), and in some variations, the retaining material (1112) isreleasably coupled to the expandable member (1110). In this way,positioning of the retaining material (1112) is easily facilitated asshown in FIG. 11E.

After the retaining material (1112) has been properly positioned aboutthe intussuscepted tissue, an anchor introducer expander (1116) may beexpanded to radially expand one or more anchor introducers (1118), asshown in FIG. 11F. As described above, anchor introducers (1118) houseone or more anchors (1120) therein for delivery or deployment throughthe intussuscepted tissue and in variations where it may be desirable,at least a portion of retaining material (1112). After the anchorintroducers (1118) are expanded, anchors (1120) are deployed therefromusing any suitable deployment or actuation technique, as shown in FIG.11G. In some variations, the anchors (1120) are deployed using a pushrod (not shown). When a retaining material (1112) is employed, theanchors (1120) pierce through at least a portion of the retainingmaterial (1112) securing the intussusception as shown in FIG. 11H.Safety mechanisms may ensure that neither the anchor introducers (1118)or anchors (1120) go further than the operator desires. These safetymechanisms may include, but are not limited to, a protective portion(not shown) around the expandable member (1110) or guides (not shown)that keep the anchor introducers or anchors at a safe range. Theexpandable member (1110) may then be hyperextended to a collapsedconfiguration as shown in FIG. 11H, and after the sizing component(1108) and anchor introducer expander (1118) are returned to theirdelivery configurations, the device is withdrawn proximally from thebody as shown by the arrow in FIG. 11I, leaving the retaining material(1112) and anchors (1120) to secure the intussusception (1002) as shownin FIG. 11J. When a sheath is used, as described above, the sheath mayor may not be advanced over the device, before the device is withdrawn.

FIGS. 12A-12D depict the anchor deployment in more detail. Shown thereis anchor introducer (1118) positioned adjacent the intussuception(1002) as shown in FIG. 12A. The anchor introducer (1118) has beenexpanded by anchor introducer expander (1116), and is then advancedthrough intussusception (1002) and at least a portion of retainingmaterial (1112) as shown in FIG. 12B. As mentioned in detail above, theanchor introducer may have a pointed or blunt end, and may be capable ofpiercing tissue. The anchor introducer may also simply be a conduit forpositioning the anchor, or may be a conduit for airflow, which may ormay not be used to improve suction. The anchor (1120) is then deployedfrom the anchor introducer (1118) via its distal end, or an aperturethereon as shown in FIG. 12C. The anchor introducer is then collapsedand withdrawn (e.g., when the intussusception device is withdrawn)leaving the anchor to secure the intussusception, as shown in FIG. 12D.The intussusception creates a serosal (S) to serosal (S) contact surfacethrough which the anchor is deployed, helping to ensure that theintussusception is properly secured. It should be understood, that ateach step of the method just described, feedback mechanisms (e.g.,resistance, pressure force feedback, visualization, auditory, tactile,etc.) may be used to guide the procedure.

While the methods described here depict a single retaining material forapposition against a distal mucosal surface (M_(d)), a retainingmaterial may be placed against the proximal mucosal surface (M_(p)) ofthe intussuscepted tissue as well, and as described above, in somevariations, no retaining material is used. It should be understood thatwhile the anchor (1120) shown in FIGS. 12C and 12D is a T-tag havingends that expand from a reduced profile delivery configuration to formcross-bars, the anchors may have any suitable shape as described above.When T-tags are used, an alternative deployment mechanism is to mimicthe use of a tagging gun. In this variation, an end of an anchor couldbe expanded on the proximal mucosal surface (M_(p)), and the anchorintroducer expander (1116) then advanced through the intussusception(1002) and at least a portion of the retaining material (1112). Thedistal portion of the anchor may then be deployed from the anchorintroducer (1118) to secure the intussusception (1002).

In some variations, it may be advantageous to minimize the pressureapplied to the stomach walls. This may help reduce pressure necrosis andhelp facilitate long-term placement of the anchors. Also, to avoidcomplete obstruction at the intussusception due to post-surgicalswelling, a retaining material may be used on the distal mucosalsurface, and may have a looser configuration at deployment to allow forpost-procedure tissue swelling that may occur as a result of the tissuemanipulation. The retaining material may also be adjusted or removed(e.g., at a follow-up visit), in accordance with the descriptions above,to change the aperture size of the gastric stricture.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it will be readily apparent to those of ordinary skill inthe art in light of the teachings of this invention that certain changesand modifications may be made thereto without departing from the spiritand scope of the appended claims.

1. A method for creating intussusception in a stomach comprising:transorally advancing a device to a position inside the stomach, thedevice having a proximal portion and a distal portion, the distalportion comprising an expandable member, the expandable member having aproximal end, distal end, inner surface, and outer surface, and defininga cavity therein to receive tissue; expanding the expandable member,such that the proximal end of the expanded expandable member defines aproximal end of the cavity; drawing stomach tissue through the proximalend of the cavity into a distal portion of the cavity of the expandedexpandable member using suction to telescope a first region of stomachtissue into a second region of stomach tissue, thereby forming theintussusception and a stomach portion proximal to the intussusceptionand distal to a gastroesophageal junction; and securing theintussusception with one or more anchors, wherein fibrosis occurs sothat the intussusception remains secured irrespective of the one or moreanchors.
 2. The method of claim 1 wherein securing the intussusceptioncomprises passing the one or more anchors at least partially through atleast one retaining material.
 3. The method of claim 2 wherein the atleast one retaining material is biodegradable.
 4. The method of claim 2wherein the at least one retaining material comprises an inflatableportion.
 5. The method of claim 2 wherein the at least one retainingmaterial is adjustable.
 6. The method of claim 2 wherein the at leastone retaining material is porous, mesh like, or woven.
 7. The method ofclaim 1 further comprising positioning a first retaining materialagainst a proximal mucosal surface of the intussusception andpositioning a second retaining material against a distal mucosal surfaceof the intussusception.
 8. The method of claim 7 wherein securing theintussusception comprises passing the one or more anchors at leastpartially through the first retaining material and at least partiallythrough the second retaining material.
 9. The method of claim 7 whereinthe first retaining material is substantially cylindrical in shape. 10.The method of claim 1 further comprising adjusting the intussusception.11. The method of claim 10 wherein adjusting the intussusceptioncomprises adjusting one or more retaining materials.
 12. The method ofclaim 1 wherein the one or more anchors are biodegradable.
 13. Themethod of claim 1 wherein the one or more anchors are T-tags.
 14. Themethod of claim 1 wherein securing the intussusception comprisespositioning a first end of the one or more anchors adjacent a proximalmucosal surface of the intussusception and advancing a second end of theone or more anchors through the intussusception to a distal mucosalsurface of the intussusception.
 15. The method of claim 1 wherein theexpandable member comprises one or more prongs.
 16. The method of claim15 further comprising collapsing the expandable member to a low profileconfiguration.
 17. The method of claim 1 wherein the device comprises atleast one retaining material attached to the expandable member.
 18. Themethod of claim 17 wherein the at least one retaining material isattached to an inner portion of the expandable member.
 19. The method ofclaim 1 further comprising positioning the device using a sizingcomponent.
 20. The method of claim 1 further comprising positioning thedevice using visual markers on the device.
 21. The method of claim 1wherein securing the intussusception comprises deploying two or moreanchors.
 22. The method of claim 21 wherein securing the intussusceptioncomprises deploying the two or more anchors simultaneously.
 23. Themethod of claim 21 wherein securing the intussusception comprisesdeploying the two or more anchors sequentially.
 24. The method of claim1 further comprising visualizing at least a portion of the stomach. 25.The method of claim 24 wherein visualizing comprises visualizingdirectly.
 26. The method of claim 24 wherein visualizing comprisesvisualizing ultrasonically.
 27. The method of claim 24 whereinvisualizing comprises visualizing fluoroscopically.